Anxiety StateNCT05752708
Perioperative Anxiety Risk Factors in Parents of Children Undergoing Thoracic Surgery
An observational study of Anxiety State and Anxiety Postoperative, run by National Institute for Tuberculosis and Lung Diseases, Poland at 1 site in Poland.
Trial summary
Risk factors associated with perioperative anxiety in parents of pediatric patients undergoing thoracic surgery are unknown. It is therefore necessary to identify them in order to better understand, above all, modifiable factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety State, Anxiety Postoperative, Parents
- What is being tested?
- Diagnostic Test
- How many people
- 123 participants
- Where
- 1 sitePoland
- Study dates
- 16 Jan 2023to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parents of children undergoing thoracic surgery in the Department of Thoracic Surgery of the Institute of Tuberculosis and Lung Disease, Rabka Zdrój Branch.
Who may be able to join
- parent of child <18 years
- parent of child undergoing thoracic surgery
- parent of child with intravenous or epidural postoperative analgesia
- parent of child with 1-3 score according to the American Society of Anesthesiologists
Who cannot join
- a parent of a nationality other than Polish
- difficult communication with parent
- parent of a child undergoing oncological treatment
- parent of a child without chest drainage
- lack of parental consent.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
National Institute for Tuberculosis and Lung Diseases
Warsaw, Masovian Voivodeship, 01-138
Lucyna Tomaszek, dr hab. n. med., +48182676060 ext. 243, ltomaszek@igrabka.edu.pl
About this study
Official title: Evaluation of Perioperative Anxiety Risk Factors in Parents of Children Undergoing Thoracic Surgery
Risk factors associated with perioperative anxiety in parents of pediatric patients undergoing thoracic surgery are unknown. It is therefore necessary to identify them in order to better understand, above all, modifiable factors. This will allow the implementation of psychological interventions tailored to the individual needs of parents to strengthen their coping mechanisms before surgery, and thus facilitate the recovery process of their children after surgery.
The purpose of the study is:
- assessment of the level of anxiety experienced by parents before and after thoracic surgery,
- assessment of risk factors for parents' perioperative anxiety,
- assessment of the relationship between parents' perioperative anxiety and satisfaction with postoperative analgesia
Read the detailed description
According to the literature, parents of children undergoing various types of surgical procedures are accompanied by high levels of anxiety. It was found that the level of anxiety is higher in female parents and is related to the child's age, fear of postoperative pain in children, the scope of information about the course of surgery and anesthesia, and potential complications that may occur during and after the child's operation. Parental anxiety correlates positively with child anxiety. High levels of anxiety in children can lead to many undesirable clinical, psychological and behavioral symptoms during hospitalization (delirium, increased postoperative pain, greater need for analgesia) and after discharge from the hospital (separation anxiety, sleep disorders, aggression, enuresis).
- Conditions
- Anxiety State, Anxiety Postoperative, Parents, Surgery, Thoracic, Satisfaction
- Being tested
- Diagnostic Test
- Keywords
- anxiety, parents, thoracic surgery, perioperative, parents' satisfaction
- Medical subject headings
- Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic TestDiagnostic test
Evaluation of perioperative anxiety in parents of children undergoing thoracic surgery using standardized tests: The Amsterdam Preoperative Anxiety and Information Scale (APAIS), the State-Trait Anxiety Inventory (STAI).
What is being measured
The primary outcome is the main question the study is designed to answer.
Parents' anxiety and information requirement in the preoperative phase
The Amsterdam Preoperative Anxiety and Information Scale (APAIS) consists of six items. The items are rated on a five point Likert scale with the end poles "not at all" (1) and "extremely" (5). It represents the two scales anxiety (Item 1, 2, 4 and 5) and need-for-information (Items 3 and 6). A total value is calculated by adding up the two scales anxiety and need-for-information. A higher score means higher preoperative anxiety and a greater need for information.
Measured: before surgery
Parents' anxiety state
Anxiety was determined with a Polish version of the State-Trait Anxiety Inventory (STAI; range: 20-80 pts). The instrument consisting of two separate 20-item scales measuring state and trait anxiety. The results will be expressed as sten scores, from 1-10 (1-4 = low level of anxiety, 5-6 = moderate level of anxiety, >7 = high level of anxiety).
Measured: before surgery, before discharge from the hospital
Secondary outcomes (2)
Parents' satisfaction
Satisfaction is assessed on a five-point scale, where 1 means the lowest satisfaction and 5 the highest.
Measured: up to discharge from the hospital
Socio-demographic factors
Socio-demographic variables include: age, sex, education, marital status, income, place of residence, number of children, number of operations/hospitalizations of the child, scope of information obtained before the operation, postoperative pain and complication in a child
Measured: perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start16 Jan 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute for Tuberculosis and Lung Diseases, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucyna Tomaszek, PhD, Principal investigator, National Institute for Tuberculosis and Lung Diseases, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752708
- Sponsor's protocol ID
- KB-74/2022
- Status last verified
- Apr 2024
- First submitted
- 21 Feb 2023
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perioperative Anxiety Risk Factors in Parents of Children Undergoing Thoracic Surgery
- ClinicalTrials.gov ID
- NCT05752708
- Acronym / sponsor ID
- KB-74/2022
- Conditions
- Anxiety State, Anxiety Postoperative, Parents, Surgery, Thoracic, Satisfaction
- Keywords
- anxiety, parents, thoracic surgery, perioperative, parents' satisfaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- National Institute for Tuberculosis and Lung Diseases, PolandUniversity, hospital or other
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Risk factors associated with perioperative anxiety in parents of pediatric patients undergoing thoracic surgery are unknown. It is therefore necessary to identify them in order to better understand, above all, modifiable factors. This will allow the implementation of psychological interventions tailored to the individual needs of parents to strengthen their coping mechanisms before surgery, and thus facilitate the recovery process of their children after surgery.
The purpose of the study is:
- assessment of the level of anxiety experienced by parents before and after thoracic surgery,
- assessment of risk factors for parents' perioperative anxiety,
- assessment of the relationship between parents' perioperative anxiety and satisfaction with postoperative analgesia
Detailed description
According to the literature, parents of children undergoing various types of surgical procedures are accompanied by high levels of anxiety. It was found that the level of anxiety is higher in female parents and is related to the child's age, fear of postoperative pain in children, the scope of information about the course of surgery and anesthesia, and potential complications that may occur during and after the child's operation. Parental anxiety correlates positively with child anxiety. High levels of anxiety in children can lead to many undesirable clinical, psychological and behavioral symptoms during hospitalization (delirium, increased postoperative pain, greater need for analgesia) and after discharge from the hospital (separation anxiety, sleep disorders, aggression, enuresis).
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parents of children undergoing thoracic surgery in the Department of Thoracic Surgery of the Institute of Tuberculosis and Lung Disease, Rabka Zdrój Branch.
Key inclusion criteria (4 listed)
- parent of child <18 years
- parent of child undergoing thoracic surgery
- parent of child with intravenous or epidural postoperative analgesia
- parent of child with 1-3 score according to the American Society of Anesthesiologists
Key exclusion criteria (5 listed)
- a parent of a nationality other than Polish
- difficult communication with parent
- parent of a child undergoing oncological treatment
- parent of a child without chest drainage
- lack of parental consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic TestEvaluation of perioperative anxiety in parents of children undergoing thoracic surgery using standardized tests: The Amsterdam Preoperative Anxiety and Information Scale (APAIS), the State-Trait Anxiety Inventory (STAI). | Diagnostic test | – |
Primary outcome
Parents' anxiety and information requirement in the preoperative phase
Time frame: before surgery
The Amsterdam Preoperative Anxiety and Information Scale (APAIS) consists of six items. The items are rated on a five point Likert scale with the end poles "not at all" (1) and "extremely" (5). It represents the two scales anxiety (Item 1, 2, 4 and 5) and need-for-information (Items 3 and 6). A total value is calculated by adding up the two scales anxiety and need-for-information. A higher score means higher preoperative anxiety and a greater need for information.
Parents' anxiety state
Time frame: before surgery, before discharge from the hospital
Anxiety was determined with a Polish version of the State-Trait Anxiety Inventory (STAI; range: 20-80 pts). The instrument consisting of two separate 20-item scales measuring state and trait anxiety. The results will be expressed as sten scores, from 1-10 (1-4 = low level of anxiety, 5-6 = moderate level of anxiety, >7 = high level of anxiety).
2 secondary outcomes
Parents' satisfaction
Time frame: up to discharge from the hospital
Socio-demographic factors
Time frame: perioperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucyna Tomaszek, PhD principal investigator
National Institute for Tuberculosis and Lung Diseases, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety State and Anxiety Postoperative, run by National Institute for Tuberculosis and Lung Diseases, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucyna Tomaszek, dr hab n. med. (+480182676060 ext. 243, ltomaszek@igrabka.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parents' anxiety and information requirement in the preoperative phase (time frame: before surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.